Clinical Research Associate Ii

2+ years

$113K/yr - $152.9K/yr

Remote

10 May 17, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate II (CRA II)

Location: Europe or North America (various locations)

Type: Full-time

Position Summary:

The CRA II is a seasoned professional responsible for monitoring and managing clinical research studies. Key responsibilities include overseeing study site management, ensuring patient safety, maintaining data quality, and providing audit support. The CRA II works independently as a member of the study team.

Essential Functions:

Manage all aspects of study site management to ensure patient safety and data quality.
Provide guidance on audit readiness standards and assist in audit preparation.
Update and maintain study-specific trial management tools/systems.
Assist in site start-up procedures, including feasibility assessments and regulatory submissions.
Assist in negotiation of study budgets and investigator contracts.
Conduct various site visits, including pre-study, initiation, routine monitoring, and close-out visits.
Document activities and ensure compliance with SOPs and regulatory requirements.
Communicate effectively with site personnel and project management teams.
Perform investigational product inventory and reconciliation.
Review and resolve data discrepancies and serious adverse events.
Prepare reports for internal validation and cross-validation studies.
Travel as required, up to 60% on average.

Qualifications:

Minimum Required:

Bachelor's degree in life science, pharmacy, or related discipline (Europe) OR 4-year college degree (North America)
Two (2) years or more experience as a CRA in a CRO or pharmaceutical/biotech industry
Excellent communication and organizational skills
Ability to travel overnight, up to 60%
Fluency in English, and proficiency in the local language (if applicable)

Preferred:

Graduate or postgraduate degree
Experience in oncology or rare disease trials
Experience with EDC trials and EHR records
Relevant site start-up experience for the particular country

Competencies:

Self-motivation and ability to work independently and in a team environment
Understanding of clinical trials methodology and protocols
Professionalism and positive interpersonal skills
Proficiency in data collection and formal presentations

Compensation Range: $113,000 — $152,900 USD (annual base salary)

Benefits: Eligible for discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, paid time off for sick leave and vacation, among others.

Precision Medicine Group is an Equal Opportunity Employer, committed to diversity and inclusion. All employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

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Clinical Research Associate Ii

Job Description

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